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Icahn School of Medicine at Mount Sinai researchers will present several landmark studies at the 2013 American Society of Clinical Oncology (ASCO) meeting May 31-June 4, 2013 in Chicago, including data on the likelihood of spousal human papillomavirus (HPV) oral infection, new gene signatures in melanoma, and issues with high readmission rates after cancer surgery.

Highlights of Mount Sinai research at ASCO:

Oral HPV Not Prevalent in Spouses of People with HPV-Positive Throat Cancer (Under Embargo Until 6:30 AM CDT on Saturday, June 1, 2013)

In the first study of its kind, researchers including Marshall Posner, MD, Medical Director of the Head and Neck Medical Oncology Program at Mount Sinai, sought to determine the prevalence of the human papillomavirus (HPV) in spouses of people with HPV-positive throat cancer, which is derived from the strain of HPV known as HPV16. They evaluated the viral load of 83 couples in which one partner had an HPV16-positive throat cancer, using a novel oral rinse and gargle test. They found that 54 percent of people with HPV16-positive throat cancer had evidence of HPV16, the strain associated with this type of cancer, at diagnosis, and six percent had it after a year, despite treatment. In their long-term partners, prevalence of any HPV was five percent in female partners of men with HPV16-positive throat cancer and 29 percent in male partners of women with HPV-positive throat cancer—findings that are comparable to the general population.

“Recent research suggests that husbands of women with cervical cancer are at greater risk for a future HPV16 positive throat cancer, and patients with throat cancer have expressed reasonable concerns about infecting their spouses with the virus,” said Dr. Posner. “Ours is the first trial to evaluate the prevalence of HPV in long-term partners of people with throat cancer, and the findings should reassure those in long-term relationships that their risk is very low.”

Expression levels of immune genes in surgically removed primary melanoma tumors predicts likelihood of recurrence or death from melanoma, according to research presented by Yvonne M. Saenger, MD, Assistant Professor of Medicine in the Division of Hematology and Oncology and Assistant Professor of Dermatology at the Icahn School of Medicine at Mount Sinai. In this study, 76 patient samples were analyzed using a gene signature test to identify damaged pieces of genetic material. The researchers identified a panel of 21 genes as predictive markers of recurrence and mortality.

“These genes are important in immune surveillance and our data suggest that the immune system is continuously patrolling tumors and that high levels of immune activity within the primary tumor are protective against bad outcomes,” said Dr. Saenger. “This gene signature test allowed us to precisely analyze immune gene expression, which will give clinicians a clearer prognosis and better tailor treatment for patients.”

In a second study, Dr. Saenger and her team identified genetic material in the blood of 478 metastatic melanoma patients treated with tremelimumab, a drug which stimulates patients’ immune systems to attack their tumors. They identified four genes as biomarkers of survival.

“We’ve known for a long time that patients with melanoma face different odds depending on how their immune system copes with the disease, but soon we may be able to determine which patients are particularly likely to benefit from immune treatments and which ones should receive other types of therapies,” said Dr. Saenger.

The 30-day preventable readmission rate after initial hospitalization for cancer surgery is higher in non-teaching hospitals and among black patients, according to researchers led by Nina A. Bickell, MD, MPH, Professor of Health Evidence and Policy; and Umut Sarpel, MD, Assistant Professor of Surgery, Surgical Oncology at Mount Sinai. The research team evaluated the records of 21,945 patients who were hospitalized for cancer surgery in 2009. They found an overall readmission rate of 9.3 percent, with a higher rate in non-teaching hospitals compared to teaching hospitals (11.2 and 8.6 percent, respectively). In teaching hospitals, there was no racial difference in readmissions, but in non-teaching hospitals, the readmission rate among black patients was 15.1 percent.

"There is a major effort at hospitals around the country to reduce readmissions and help alleviate the burden of health care costs associated with readmissions,” said Dr. Bickell. “Readmissions rates are a measure of health care quality, and our findings indicate that there may be a disparity in clinical protocols between teaching and non-teaching hospitals that contributes to this issue.”

Research on Practical Ways to Improve Prognosis and Treatment of Head and Neck Cancer

CT scans may help clinicians determine how far head and neck cancer has advanced, according to research from Mount Sinai. Clinicians use a predictive marker called extracapsular extension (ECE), to evaluate whether cancer cells contained within a lymph node have spread through the outer capsule encasing the lymph node. Typically, ECE is evaluated after surgery when the patients' lymph nodes are examined under a microscope by a pathologist. In a retrospective study of 111 patients, Ben Kann, a Doris Duke Research Fellow, and Vishal Gupta, MD, Assistant Professor of Radiation Oncology at Mount Sinai, used CT scans to evaluate extracapsular extension (ECE), and found that the imaging technique was an effective tool for measuring prognosis.

“To our knowledge, this is the first study to assess the value of extracapsular extension on CT scan in determining disease prognosis,” said Kann. “The current standard of care requires surgical removal to assess extracapsular extension in head and neck cancer, but our findings suggest that imaging may be a useful tool, particularly for patients who do not undergo surgery. This may benefit other tumor types as well.” (Saturday, June 1, 1:15 PM - 5:15 PM CDT, e450A)

A second retrospective study led by Lale Kostakoglu, MD, Professor of Radiology at Mount Sinai, used another imaging technique called FDG-PET/CT and compared it to CT plus clinical examination to detect early relapse. The study showed that PET/CT was superior in detecting more disease recurrences or second primary tumors and did so earlier than CT plus clinical examination. (Saturday, June 1, 8:00 AM – 11:45 AM CDT, S Hall A2)

Another study from Mount Sinai’s Head and Neck Cancer program found that progression-free survival (PFS) should be a substitute endpoint for overall survival (OS) in head and neck cancer. Anti-epidermal growth factor receptor (EGFR) inhibitors show promise in the treatment of this cancer, but many have failed to achieve FDA approval due to failure to reach the primary endpoint of significant improvement in OS. Krzysztof J. Misiukiewicz, MD, Assistant Professor of Medicine at Mount Sinai led a research team that analyzed all published Phase III trials in EGFR inhibitors to investigate PFS as a surrogate, or replacement endpoint, for OS. They found that panitumumab, another EGFR inhibitor, showed comparable benefit in PFS, indicating that PFS may be used as a surrogate endpoint in light of newly approved second-line therapies and improved outcomes over time. (Saturday, June 1, 8:00 AM – 11:45 AM CDT, S Hall A2)

“Mount Sinai is conducting very practical, thought-provoking research in cancer, which has implications for clinical practice now, rather than 10 years from now,” said Dr. Posner, who is also the Medical Director of the Clinical Trials Office for the Tisch Cancer Institute at Mount Sinai. “This research has important implications in the current health care climate as well, as applying existing imaging techniques, re-evaluating existing drugs, tailoring treatment, and reducing readmissions will all impact health care utilization.”

The Tisch Cancer Institute’s Cancer Clinical Trials Office (CCTO) provides the infrastructure and resources required to support patient-based cancer research for the Tisch Cancer Institute at Mount Sinai. The CCTO serves as the central location for cancer protocols and provides a centralized database of protocol-specific data. The CCTO maintains a current list of active protocols and enrollments for use by disease teams and TCI management and reports on the status of open protocols.

The Tisch Cancer Institute (TCI) is a world-class translational cancer institute established in December 2007. TCI has recruited more than 30 acclaimed physicians and researchers specializing in basic research, clinical research, and population science; built outstanding programs in solid tumor oncology; enhanced existing robust programs in hematological malignancies; and advanced the study of cancer immunology and vaccine therapy. The completion of the Leon and Norma Hess Center for Science and Medicine in 2012 is enabling the recruitment of up to 20 additional cancer researchers on two full research floors, with 48,000 square feet of space dedicated to cancer research.

The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai. Established in 1968, the Icahn School of Medicine at Mount Sinai is one of the leading medical schools in the United States. The Icahn School of Medicine is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty members in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.

The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation’s oldest, largest and most-respected voluntary hospitals. In 2012, U.S. News & World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nation’s top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of just 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and by U.S. News & World Report and whose hospital is on the U.S. News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.